Chemotherapy / Radiotherapy in Uterine Cervical Neoplasms

NCT03238261 | Completed DMC

• 1 other identifier: C41030310-023
• Study Type: interventional
• Target: 147
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare the use of radiotherapy and concomitant chemotherapy, with the single use of radiotherapy in the treatment of patients with stage IIIB uterine cancer, having as an outcome the three year survival rate, the disease free survival rate, the locoregional control of the disease and the security of the treatments provided. Specific objectives

1. 1.Describe and compare the demographic and clinical characteristics of both groups.
2. 2.Compare the three year survival rate in both groups.
3. 3.Compare the response to treatment in terms of locoregional control of the disease.
4. 4.Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

• Survival rate

  the disease free survival rate

  3 years

Secondary Outcomes (2)

• The response to treatment in terms of locoregional control of the disease

  3 years

• Events adverse

  3 years

Study Arms (2)

Chemotherapy and concomitant radiotherapy

EXPERIMENTAL

Radiation: Chemotherapy and concomitant radiotherapy

Radiotherapy

ACTIVE COMPARATOR

Radiation: Chemotherapy and concomitant radiotherapy

Interventions

Chemotherapy and concomitant radiotherapy RADIATION

Radiotherapy (teletherapy + high or low rate brachytherapy)

Chemotherapy and concomitant radiotherapy; Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between 18 and 80 years old, diagnosed with uterine squamous cell cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or more than 70%.

You may not qualify if:

• Having a concomitant or previous neoplasia, except for patients with skin tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10 gr/dl or above before starting the first radiotherapy session, patients with recurrent invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with active and non controlled pelvic infection by the beginning of the treatment, creatinine depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min, neutrophils count less than 1,500/ml, and pregnant or nursing woman.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia, Columbia: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 3, 2017
• Study Start: August 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2016
• Last Updated: August 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share